Implementing CtDNA And Circular DNA In Patients With Localized Pancreatic Cancer

Study Overview

Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer

The goal of this clinical trial is to investigate if plasma ctDNA and eccDNA before resection for suspicion of pancreatic ductal adenocarcinoma (PDAC) can predict early recurrence and overall survival, and to investigate if plasma ctDNA combined with CT scan and endoscopic ultrasound surveillance increases the median overall survival compared with standard-of-care surveillance.

The aim of the CIRCPAC study is to evaluate if plasma ctDNA from patients scheduled for surgical resection of PDAC can identify patients who will benefit from surgery and if plasma ctDNA can identify recurrence earlier and improve the survival and quality of life of the patients compared with standard-of-care surveillance. Patients operated for PDAC will be included in this Danish multicenter study including an observational study (Sub-study 1: 700 patients) and an interventional randomized trial (Sub-study 2: 410 patients). In Sub-study 1, patients will have blood samples drawn prior to surgery, 4 weeks after surgery, and 6 months after surgery. In Sub-study 2, patients without recurrence 4 months after surgery, will be randomized in a 1:1 manor to an experimental arm (arm A) with ctDNA guided surveillance, or to a control arm (B) with standard surveillance.

Resectable Pancreatic Cancer

DIAGNOSTIC_TEST: ctDNA

CIRCPAC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-11-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-03-27
First Submitted that Met QC Criteria 2023-03-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-03-29
First Posted (ACTUAL) 2023-03-29	Results First Posted N/A	Last Verified 2023-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: A: Experimental Patients will receive surveillance with liver enzymes, CA 19-9, history, clinical evaluation of signs of recurrence (e.g. weight loss, abdominal pain or fatigue) in combination with analysis of plasma ctDNA (90 ml blood drawn per visit) every 3 months unt	DIAGNOSTIC_TEST: ctDNA ctDNA guided surveillance
NO_INTERVENTION: B: Control Patients will receive surveillance until recurrence according to current Danish guidelines with liver enzymes, history and clinical evaluation every 3 months for two years and then every 6 months until 36 months. If an increase in liver enzymes is seen or

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: A: Experimental

Patients will receive surveillance with liver enzymes, CA 19-9, history, clinical evaluation of signs of recurrence (e.g. weight loss, abdominal pain or fatigue) in combination with analysis of plasma ctDNA (90 ml blood drawn per visit) every 3 months unt

DIAGNOSTIC_TEST: ctDNA

ctDNA guided surveillance

NO_INTERVENTION: B: Control

Patients will receive surveillance until recurrence according to current Danish guidelines with liver enzymes, history and clinical evaluation every 3 months for two years and then every 6 months until 36 months. If an increase in liver enzymes is seen or

Primary Outcome Measures	Measure Description	Time Frame
Sub-study 1 ctDNA	Preoperative plasma ctDNA levels before PDAC resection predicting early recurrence.	36 months
Sub-study 1 eccDNA	Preoperative plasma eccDNA levels before PDAC resection predicting early recurrence.	36 months
Sub-study 2 ctDNA DFS	Number of patients with recurrence assessed by ctDNA	3 years from surgery for PDAC
Sub-study 2 ctDNA OS	Overall survival of patients in arm A compared with patients in Arm B	3 years from surgery for PDAC
Sub-study 2 eccDNA	Number of patients with recurrence assessed by eccDNA	3 years from surgery for PDAC

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Julia S Johansen, MD

Phone Number: +45 38689241

Email: Julia.sidenius.johansen@regionh.dk

Study Contact Backup

Name: Sidsel C Lindgaard, MD

Phone Number: +45 38682984

Email: sidsel.christy.lindgaard@regionh.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

Sub-study 1: Suspicion of PDAC tumor stage I-III, scheduled for pancreatic resection, with or without preoperative neoadjuvant chemotherapy.
Sub-study 2: .

PDAC tumor stage I-III
Has received intended curative resection (R0/R1) of PDAC
No signs of local recurrence or metastatic disease at a CT scan 4 months after the operation

Other cancers (excluding skin cancer other than melanoma) later than 3 years before inclusion
Patients who are unlikely to comply with the protocol, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Aarhus University Hospital
University of Copenhagen
Odense University Hospital

Investigators

PRINCIPAL_INVESTIGATOR: Julia S Johansen, MD, Copenhagen University Hospital - Herlev and Gentofte

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record